Kornimate/medical-research-clean huggingface dataset:
effect of daily consumption of orange maize on breast milk retinol in lactating zambian women

Conditions: Vitamin A Deficiency

Summary: the purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating zambian women.

lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin a biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin a capsule, or 3) white maize and a corn oil capsule. the 'orange maize' and 'vitamin a' groups received \~600 ug rae/d as provitamin a biofortified maize or retinyl palmitate, respectively. the 'white maize' group was a negative control group that did not receive any supplemental vitamin a.

Eligibility criteria:
inclusion criteria: * apparently healthy lactating women 18-35 years of age * who are breastfeeding a single infant, 4-12 mo of age. exclusion criteria: * pregnancy, * chronic disease, * hb concentration \<90 g/l, * signs or symptoms of vitamin a deficiency

Keywords: biofortification vitamin a maize beta-carotene breastmilk zambia
sertaconazole 2% cream to improve symptoms associated with atopic dermatitis

Conditions: Skin Alterations Associated With Atopic Dermatitis

Summary: investigation aimed to explore the efficacy of a topical sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis


Eligibility criteria:
inclusion criteria: * informed consent * atopic dermatitis patients with scoring atopic dermatitis (scorad) ≤ 40 * atopic lesion localisation: arms; additional legs, neck exclusion criteria: * scorad \> 40 * unstable, uncontrolled medical status (e.g. active systemic or topical infection) * active immunosuppression or cancer * narcotics- or alcohol abuse * participation in another clinical trial until one month prior inclusion * known allergies against an ingredient of the investigational medicinal product * different periods of grace for certain pre-treatments, e.g. topical corticosteroids, immune modulating drugs * pregnancy or lactation

Keywords: skin alterations atopic dermatitis
a study to look at how safe nnc0268-0965 is in healthy people and people with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Healthy Volunteers

Summary: this study is investigating the safety and tolerability of the new medicine nnc0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. this first part of the study is conducted in healthy people, while there is a second part involving people with type 1 diabetes. the study will test how insulin 965 is tolerated by the participants' body, how it is taken up in the participants' blood, how long it stays there and how blood sugar is lowered. participants will either get the new insulin 965 or placebo (an injection that does not contain active medicine) - which treatment you get is decided by chance. it is the first time that insulin 965 is tested in humans. participants will get one injection of either insulin 965 or placebo under the skin of the left thigh. the study will last for about 5 weeks. participants will have 6 clinic visits with the study doctor. people cannot be in the study if the study doctor thinks that there are risks for their health.


Eligibility criteria:
inclusion criteria: * part 1 (healthy subjects): 1. male, aged 18-55 years (both inclusive) at the time of signing informed consent. * part 2 (subjects with type 1 diabetes mellitus): 1. male or female, aged 18-55 years (both inclusive) at the time of signing informed consent. 2. diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening. 3. male subject or female subject of non-child bearing potential. non-child bearing potential being surgically sterilized (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause). 4. current daily total insulin treatment between 0.2 (i)u/kg/day and 1.2 (i)u/kg/day (both inclusive). 5. hba1c equal to or below 8.5%. 6. fasting c-peptide below 0.30 nmol/l. exclusion criteria: * (part 1 and part 2) 1. male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). in addition, subjects must not donate sperm for the duration of the trial.
gut mucosal microbiota is associated with colorectal cancer relapse

Conditions: Gut Microbiota; Colorectal Cancer

Summary: colonic microbiome has been found to contribute to the development of colorectal cancer. we speculate that gut microbiota related to colorectal cancer relapse after curative treatment. this study aim to discover if any difference of gut microbiota exist in patients who suffer from cancer relapse compared with patients who do not. finally develop patient-centred programmes of surveillance protocols base on microbiota analysis.

treatments for colorectal cancer of all stages have evolved considerably over the past two decades, resulting in improved long-term outcomes. after curative treatment, however, 30% of patients with stage i-iii and up to 65% of patients with stage iv colorectal cancer develop recurrent disease. the human colon plays host to a diverse and metabolically complex community of microorganisms. while the colonic microbiome has been found to contribute to the development of colorectal cancer. investigators speculate that gut microbiota related to colorectal cancer relapse after curative treatment. patients are routinely offered surveillance in order to detect disease recurrence at an early, asymptomatic stage, with the intention of improving survival. nevertheless, controversy continues to surround the optimal surveillance protocols. investigators aim to discover if any difference of gut microbiota is exist in patients who suffer from relapse compared with patients who do not. future surveillance after colorectal cancer treatment should focus on risk-stratification and should incorporate current knowledge on risk of recurrence in relation to the biology of the tumour as well as gut microbiota feature. finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Eligibility criteria:
inclusion criteria: * requirements of informed consent and assent of participant, parent or legal guardian as applicable * patients with colorectal cancer scheduled for radical coloproctectomy and between the age of 18 and 75 years old without considering sex. * patients with bmi= 18.5-23.9 * participants can follow the visit plan exclusion criteria: * patients with colorectal cancer with distant metastasis * chronic renal diseases and hepatic cirrhosis * chronic ischemic heart disease with unstable angina, chronic heart failure at class iii or iv and acute myocardial infarction in the last 6 months * individuals with a history of chronic diarrhea * individuals with a history of diabetes mellitus * individuals with a history of hypertension * individuals with a history of autoimmune diseases * use of antibiotics and probiotics 3 mouth before samples collection * individuals with a history of abdominal operation due to any reason * individuals with any history of cancer other than colorectal cancer * individuals with inflammatory bowel disease

Keywords: microbiota colorectal cancer relapse surveillance
otx-14-003: a phase 3 study evaluating the safety and efficacy of otx-dp for the treatment of ocular inflammation and pain after cataract surgery

Conditions: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation

Summary: the objective of the study was to evaluate the safety and efficacy of otx-dp (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation


Eligibility criteria:
inclusion criteria: * has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber lens * has a potential post-operative pinhole corrected snellen va of at least 20/200 or better in both eyes exclusion criteria: * any intraocular inflammation in the study eye present during the screening slit lamp examination * score greater than "0" on the ocular pain assessment in the study eye at screening * any intraocular inflammation in the study eye present during the screening slit lamp examination
efficacy, safety and neural mechanism of stellate ganglion block in the treatment of anxiety. disorder.

Conditions: Anxiety Disorders; Stellate Ganglion Block

Summary: 1. in this study, ultrasound-guided stellate ganglion block(sgb) will be used in the treatment of anxiety disorders, combined with relevant scales, hrv indicators and resting state functional magnetic resonance data, to explore the safety and effectiveness of sgb in the treatment of anxiety disorders, and to explore whether its mechanism of action is related to the excitability of sympathetic nervous system and the activity changes of insular cortex. 2. verify the following hypothesis: (1) sgb is a safe, well-tolerated and acceptable treatment technique; (2) after sgb treatment, the anxiety symptoms of the patients were relieved to a certain extent and the psychological function was restored; (3) the sympathetic excitability of patients after sgb treatment is reduced, and this effect can be monitored by heart rate variability; (4) the activity of insular cortex decreased after sgb treatment.


Eligibility criteria:
inclusion criteria: 1. aged 18-60 years old 2. diagnosed with various types of anxiety disorders according to the dsm-5, and meet the diagnostic criteria for pain disorders 3. right-handed 4. voluntarily join the study and sign the informed consent. exclusion criteria: 1. suicidal thoughts and behaviors 2. serious physical disease 3. diseases of the nervous system or other mental diseases 4. contraindications for mri examination 5. during pregnancy or lactation 6. allergy to narcotic drugs 7. contraindications with stellate ganglion block
aquatic and land exercises in chronic low back pain

Conditions: Chronic Low-back Pain

Summary: aquatic and land exercises on chronic low back pain

the effect of aquatic and land exercises on pain, health related quality of life, kinesiophobia and disability in chronic low back pain

Eligibility criteria:
inclusion criteria: * patients had to be diagnosed with clinical examination and radiological findings of low back pain from at least 6 months. exclusion criteria: * acute pain

Keywords: aquatic exercises chronic low back pain, land exercises pain, functional status
a pilot study of lycopene supplementation in prostatic intraepithelial neoplasia

Conditions: Prostatic Intraepithelial Neoplasia

Summary: the purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(psa) in men with high grade intraepithelial neoplasia (hgpin).

observational studies suggest higher lycopene intake or higher lycopene blood levels are associated with a lower risk for prostate cancer. two recent trials of lycopene supplementation conducted in men with prostate cancer, during the three weeks prior to radical prostatectomy, found a reduction in serum psa suggesting a regression of prostate cancer. high grade intraepithelial neoplasia (hgpin)is thought to be a precancerous lesion, and men with hgpin have an elevated risk of prostate cancer diagnosis on subsequent biopsy. the objective of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(psa)over four months of supplementation. serum psa is compared in men randomized to 30 mg/day lycopene plus a standard multivitamin versus standard multivitamin alone.

Eligibility criteria:
inclusion criteria: * biopsy reported high grade prostatic intraepithelial neoplasia * and/or biopsy reported atypia * and/or persistently elevated serum prostate specific antigen with normal biopsy exclusion criteria: * biopsy diagnosed prostate cancer * serum prostate specific antigen \> 40 ng/ml * hospitalization in past six months * history of allergy to tomatoes * history of allergic dermatitis * serious concurrent illness * inability to provide informed consent

Keywords: prostatic intraepithelial neoplasia prostate-specific antigen lycopene
a multicenter clinical study of echocardiographic assessment of right heart function and implications of prognosis in diabetes

Conditions: Diabetes; Prognosis

Summary: the aims of this study are to 1. evaluate the right heart structure and function in t2dm and prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in t2dm and prediabetes patients. 2. to explore the prognostic value of right ventricular function in t2dm patients.

this study will recruit 1000 t2dm patients and 500 prediabetes and 500 healthy controls. assessing the left heart and right heart structure and function by speckle tracking echocardiography. patients with t2dm were followed up for adverse cardiovascular outcome events (myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure). and the study aimed to 1. 1. evaluate the right heart structure and function in t2dm and prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in t2dm and prediabetes patients. 2. to explore the prognostic value of right ventricular function in t2dm patients.

Eligibility criteria:
inclusion criteria: people with t2dm according to the who 2006 criteria exclusion criteria: including history or symptoms of cad valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease
a systematic study of assessment of attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: adhd is one of the most prevalent psychiatric conditions, consuming a large proportion of resources in psychiatric care, often accompanied by long waiting lists to receive proper assessment. the number of adhd cases has increased, possible due to heightened awareness of the condition. there are large prevalence differences, potentially due to variations in assessments procedures. many clinicians and parents view the diagnostic process as too extensive, taking time from treatment and interventions. in addition, assessments may be perceived as too focused on diagnostic criteria to be fully helpful. systematic research on how assessment procedures can be optimized is essentially lacking. it is largely unknown whether brief protocols including medical history, diagnostic interview, and rating scales differ from comprehensive protocols that also encompass neuropsychological testing regarding validity, reliability, patient satisfaction and cost-effectiveness. further, feasible biomarkers (e.g. heart rate variability, pupil dilation and the pupillary light reflex) of the autonomic nervous system have been proposed as indicators of diagnostic status. the aim of this study is to gain knowledge about diagnostic processes to enable valid, reliable, and cost-effective adhd assessments. using a randomized controlled trial design (n = 240 children, 8-17 years, referred to child and adolescent psychiatric units), differences between a brief and a comprehensive adhd assessment protocol regarding assessment outcome, reliability, validity, patient satisfaction, and future outcome taking gender into account will be examined. the investigators will explore diagnostic sensitivity and specificity of the included assessment instruments and estimate cost-effectiveness of the brief and comprehensive protocols to enable policy makers to make informed decisions. the project will provide important knowledge for patients and clinicians, and inform our understanding of mechanisms underpinning adhd.


Eligibility criteria:
inclusion criteria: * age 8-17 years * referral for adhd assessment exclusion criteria: * suspected intellectual disability * substance abuse * psychosis * severe depression * parent not fluent in swedish * child not living with legal guardian * child having protected identity

Keywords: assessment biomarkers patient satisfaction validity reliability
effects of a circuit training on balance in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the aim of the study is to evaluate the effects of a circuit training rehabilitation program on the perceived impact of fatigue in daily life situations and on gait and balance. half of the participants will follow the circuit training program, while the other half will follow usual care rehabilitation programs.

approximately 80% of persons with multiple sclerosis rates fatigue among the three most disabling symptoms. aerobic, balance and strength training have already been proved effective in rehabilitation, especially for persons with multiple sclerosis. fifty-two persons with multiple sclerosis will be randomly allocated to an experimental group or to a control group following usual care rehabilitation programs. experimental group will follow a circuit training rehabilitation program which combines high intensity aerobic training with balance and strength training. the study aims to verify the effects of the circuit training program on fatigue and on balance in different contexts with respect to usual care rehabilitation programs and to investigate effects of rehabilitation on immunological markers.

Eligibility criteria:
inclusion criteria: * definite diagnosis of multiple sclerosis (polman criteria); * no relapses in the previous three months; * expanded disability status scale \< 6,5; * able to walk 20 meter with or without an assistive device; * able to stand for 30 second without aid; * minimental state examination \>20; exclusion criteria: * unable to understand the aim of the study or unable to sign the informed consent form; * subjects following a steroidal drug therapy or assuming drugs affecting cardiac function; * subjects with psychiatric disorders; * subjects with cardiovascular diseases for whom aerobic training is forbidden;

Keywords: fatigue balance aerobic training
database maintenance for bariatric procedures

Conditions: Obesity, Morbid; Bariatric Surgery Candidate

Summary: bariatric surgery registry for quality control and investigational purposes.


Eligibility criteria:
inclusion criteria: * morbid obesity exclusion criteria: * unfit for surgery
reward system in autism spectrum disorder and addictive disorder

Conditions: Autism Spectrum Disorder

Summary: an mri study in subjects with autism spectrum disorder and subjects with food addictive disorder compared to healthy volunteers.

an mri study in subjects with autism spectrum disorder and subjects with food addictive disorder compared to healthy volunteers, where pathophysiology common to both disorders, based on a dysfunction of the reward system. the project we propose aims to explore the neural networks underlying these alterations in patients suffering from autism or addictive disorder.

Eligibility criteria:
inclusion criteria: arm a ˗ concerning asd patients: adult carrying the diagnosis of asd (dsm-5, ados, adi-r criteria) arm b ˗ concerning fad patients: adult diagnosed with fa presenting with food addiction (dsm-5, yfas 2.0, bes \>= 18 criteria). arm c ˗ concerning healthy volunteers : adult with no neurological and psychiatric history , absence of progressive somatic pathologies or with vital risk. for all participants: * age greater than or equal to 18 years old * without intellectual delay (iq \> 70). * able to understand and apply the instruction when an active task is proposed, according to the estimate of the investigator. * free, express, informed and written consent of the participant. * participant affiliated to a social security scheme exclusion criteria: * neuromotor disorders. * visual disturbances not corrected or incompatible with mri. * known epilepsy. * current substance use disorder with emotional distress/significant impact on functional outcome * rare genetic syndrome. * contraindications to mri (other than body circumference) * for women of childbearing age: negative urine or blood pregnancy test * person subject to a measure of judicial protection (safeguard of justice, curatorship, guardianship or family authorization)

Keywords: autism; mri;addictive disorders
the vascular and metabolic effects of sunitinib in patients with metastatic renal cell carcinoma

Conditions: Hypertension; Renal Function; Insulin Sensitivity; Renal Cell Carcinoma

Summary: rationale: the introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. however, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. moreover patients treated with angiogenesis inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to change. the treatment with angiogenesis inhibitors, will improve life expectancy of patients with various cancer diagnoses and therefore the clinical relevance of both short term and long lasting adverse events will translate into reduced quality of life. in addition, premature withdrawal of angiogenesis inhibitors due to side effects may result in lower response, shorter duration of response and possibly a shorter survival. therefore, adequate treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is of relevance for the response rate, the duration of progression free survival and overall survival and for quality of life. mechanistic insight in the pathogenesis of these side effects will help optimizing treatment. objective: the primary objective of the study is to investigate the effect of sunitinib on endothelial function, insulin sensitivity, renal function and renal blood flow. study design: single-centre non randomized observational study study population: 30 patients (\>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.


Eligibility criteria:
inclusion criteria: * subject is able and willing to sign the informed consent form * age 18 years or older * who performance status 0-2 * life expectancy ≥ 12 weeks * mrcc patients in which the treatment of choice is sunitinib exclusion criteria: * use of corticosteroids * any evidence of severe or uncontrolled diseases other than renal cell carcinoma eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease. * known risk of the patient transmitting hiv, hepatitis b or c via infected blood * patients being treated with oral anticoagulants if to be included in group a.